UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- UHR-OCT HD-OCT
研究概览
简要总结
Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.
详细描述
Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)
Main outcome measures are:
UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preretinal membrane
- •Age between 18 and 85 years
- •Combined surgery possible(phacoemulsification and vitreoretinal procedure)
排除标准
- •Age-related macular degeneration
- •Previous retinal detachment surgery
- •Previous laser treatment
结局指标
主要结局
UHR-OCT HD-OCT
时间窗: 12 months
Distance Visual acuity
时间窗: 12 months
Near Visual acuity
时间窗: 12 months
Contrast sensitivtiy
时间窗: 12 months
次要结局
- OCT Stratus 3000(12 months)
- Visual Field(12 months)